FDA.reportPublic FDA data

CurrentBody Skin™

Primary DI
00695866567110
Brand
CurrentBody Skin™
Company
Shenzhen Kaiyan Medical Equipment Co,. Ltd
Model
EY-36B
Device description
The LED Eye Perfector (Model: EY-36B) is an Over-the-Counter (0TC) device intended for use in treating wrinkles within the periorbital region.
Published
2025-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00695866567110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00695866567110006958665671106958665671100695866567110

GMDN Terms#

Term, Definition table
TermDefinition
Blue/red/infrared phototherapy lampA portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543062382
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850049532440HIGHERDOSEHG-120K2025-06-28
00731093153136CurrentBody Skin™MZ-072024-01-30
00810137610429SOLAWAVEEY-20N2025-06-28
00810137610436SOLAWAVE610432025-06-28
00850049532471HIGHERDOSEMK66-L2025-06-28
00850062024557EXOCEUTICALSSZ-22A2025-06-28
00856957008022Dr NaomiMK-042025-06-28
05060282690301LustrePR60012025-06-28
05060282690318LustrePR50012025-06-28
06970006970918NOOANCEM-2822025-06-28
06970006970925NOOANCEM-1202025-06-28
06970006971144CosmotologyEY-20R2025-06-28
06970006971212EnergyLoungerTY-012025-06-28
00843041136433Tommie copper5008LD2022-01-26
00843041136907Tommie Copper5010LD2022-01-26
00850049532297HIGHERDOSEZLD-75W2024-01-23
00731093153914CurrentBody™MK-90C2025-03-06
05060282690325LUSTRE PR70012025-03-06
00655729008235CurrentBody Skin™MK66R-B2024-01-30
06970006971649 Lumaflex ZLD-05A2024-09-02

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